StacksVerified U.S. regulatory reference

21 CFR §516.28

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
FDA will periodically update a publicly available list of MUMS-designated drugs. This list will be placed on file at the FDA Dockets Management Staff, and will contain the following information for each MUMS-designated drug:
  1. (a)The name and address of the sponsor;
  2. (b)The established name and trade name, if any, of the drug;
  3. (c)The dosage form of the drug;
  4. (d)The species and the proposed intended use for which MUMS-drug designation was granted; and
  5. (e)The date designation was granted.